Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
Responsibilities:
- Assist with certifications and self-certifications process of various Tempus products including CE-mark and IVDR regulatory process
- Completions of Technical Dossiers
- Identity self-certification or notified body certification path of products
- Assist with completion of Declaration of Conformity (EC DoC) of products
- Communication with Tempus’ Notified Body as needed
- Collaborate cross-functionally with Quality, Regulatory, R&D, Engineering, Supply Chain and Operations for continued support of International Regulatory Compliance, maintenance, and improvement of the Quality Management System (QMS).
- Support Lead Auditor with audit functions
- May be required to participate in conducting internal audits under the direction of the Lead Auditor
- Assist with completion of partnership pre-qualification questionnaires
- Oversee drafting of internal and external audit responses to closure
- Administrative audit functions as needed
- Lead partnership/client audits.
- Comply with documented Quality Management System procedures
- Completion of assigned training on time
- Perform other duties and projects as assigned
- Review QMS documentation against applicable regulations for international compliance
- Remain up to date with applicable regulations to communicate changing requirements to Management
- Assist with inspection readiness efforts and external audits
- Offer improvement strategies to existing processes
- Managing and hosting external audits including regulatory inspections and CAP/CLIA Inspections.
Required Skills:
- Superb organizational and follow through skills
- Strong interpersonal skills in the areas of written and verbal communication
- Must be creative, flexible, and able to prioritize and handle multiple projects concurrently
- Must be self-motivated and have the ability to work with minimal supervision
- Minimum of 4 years of QMS experience in the FDA regulated industry - medical devices or IVDs
- Bachelor’s degree required preferably in a life science discipline
Preferred Experience
- Some QA experience in a molecular testing laboratory (LDTs) is a plus
- Interest in obtaining Auditor certification is a plus
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We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.Additionally, for remote roles open to individuals in unincorporated Los Angeles – including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
